HENLIUS (02696) appears at the International Lung Cancer Forum with HLX43, and forward-looking data highlights the global competitiveness of the ADC platform.

On November 2nd, the "Creating the Future: International Frontiers and Innovation Forum on Lung Cancer" was held in Shanghai. This high-end academic conference, gathering leading experts in the field of lung cancer from around the world, has not only become an important platform for discussing the latest advances in lung cancer treatment, but also a key stage for Chinese local innovative drug companies to showcase their research and development capabilities and promote their globalization strategies. As an important participant in this conference, HENLIUS (02696) presented the latest key data of its core innovative product - the PD-L1 antibody-drug conjugate (ADC) HLX43, with its dazzling "high efficacy, low toxicity, broad spectrum" data, sparking widespread attention from the industry and capital markets. Grand opening of the forum, HENLIUS leads the display of Chinese innovation power According to public information, this conference invited Professor Wu Yilong from Guangdong Provincial People's Hospital, Professor Lu Shun from Shanghai Jiaotong University Affiliated Chest Hospital, and Professor Fred Hirsch from Icahn School of Medicine at Mount Sinai in New York as co-chairs of the conference. Professor Lu You from West China Hospital of Sichuan University and Professor Fan Yun from Zhejiang Cancer Hospital served as the hosts. Renowned experts from around the world took the stage one after another to engage in in-depth discussions on key topics such as clinical prevention and control of lung cancer, breakthroughs in non-small cell lung cancer (NSCLC), and new developments in immunotherapy for small cell lung cancer (SCLC). At the opening ceremony of the conference, Dr. Zhu Jun, Executive Director and CEO of HENLIUS, delivered a keynote speech titled "China's Innovation Upgrade: Assisting in Global Cancer Prevention and Control," outlining the company's strategic blueprint. Dr. Zhu pointed out that lung cancer is the most common malignant tumor globally and in China, and HENLIUS, as a pioneer in the industry focusing on lung cancer and the entire field of oncology, has successfully launched 9 marketed products, benefiting over 900,000 patients worldwide. He particularly introduced Sluralizumab, the world's first approved first-line treatment for small cell lung cancer (SCLC), independently developed by HENLIUS, which has been marketed in nearly 40 countries globally. Furthermore, Dr. Zhu also highlighted the next-generation innovative pipeline that is expected to become the company's future growth engine. He emphasized that the company is committed to achieving multiple breakthroughs in the field of lung cancer through a differentiated research and development platform and a global integrated operating system. Among them, the PD-L1 ADC HLX43, which combines the efficacy of ADC and immunotherapy, is expected to overcome the limitations of patient PD-L1 expression levels and EGFR gene mutation status, and cover a broader population of lung cancer patients. At the same time, the high-affinity EGFR antibody HLX07 has opened up a new first-line treatment pathway for EGFR high-expression populations, which account for nearly 90% of lung squamous carcinoma. This explanation sends a clear signal to the outside world: HENLIUS is not only achieving self-empowerment through the successful commercialization of its products, but also continues to invest in high-risk but high-return innovative drug research and development. Shortly afterwards, Dr. Yuan Jijun, Chief Scientific Officer of HENLIUS, systematically explained the company's research and development strategy and pipeline layout. He introduced that the company's research and development focuses on antibodies and their derivatives, and driven by three core technology engines - Hanjugator ADC platform, HAI Club platform, has built a rich and forward-looking medium- to long-term innovative pipeline. Among them, high-value projects such as HLX43, HLX3901 (DDL3xCD3xCD28 triple-specific T cell connector), HLX48 (EGFRxcMET dual-specific ADC) were identified as the stars of future research and development. This demonstration further solidifies market confidence in HENLIUS' continuous innovation capability. HLX43's impressive data debut highlights its "best-in-class" potential One of the most anticipated moments of this forum was undoubtedly the release of key data updates of HLX43 for the treatment of non-small cell lung cancer (NSCLC). This release combined data from the Chinese Phase I study (HLX43-FIH101) and the international multicenter Phase II study (HLX43-NSCLC201), systematically evaluating its efficacy and safety. The released data not only solid, but also exceeded market expectations in multiple dimensions, fully demonstrating its strong capabilities and commercial potential as a potential "best-in-class" product. First of all, the core competitiveness of HLX43 lies in its "biomarker-independent" broad-spectrum efficacy, which directly broadens its future market ceiling. Clinical data show that regardless of whether patients have squamous or non-squamous NSCLC, EGFR mutation status, PD-L1 expression level, or even the presence of brain metastasis, HLX43 can observe treatment effects. In the current context of precision medicine requiring continuous patient segmentation, the "full coverage" feature of HLX43 means that its target patient pool is much larger than that of many targeted drugs or immunotherapies that require specific biomarkers, laying a solid foundation for its potential as a "game-changer" product. Secondly, it showed a high response rate in the key population of resistant patients, directly addressing the biggest clinical pain point and establishing its irreplaceable clinical value. The data shows that in previously treated immunotherapy and chemotherapy refractory patients (which are the most urgent and limited treatment population in clinical practice), HLX43 achieved objective response rates of 33.3% (squamous) to 48.6% (non-squamous, including patients with EGFR mutations and wild type). This is of milestone significance in addressing the increasingly serious problem of immunotherapy resistance globally. Its unique "immune checkpoint blockade + targeted cytotoxicity" dual mechanism provides a lifeline to patients with no available treatment, giving it a strong advantage in market penetration and pricing potential. Furthermore, the remarkable intracranial activity adds significant weight to HLX43. In patients with poor prognosis brain metastases, HLX30.0% ORR and up to 90.0% disease control rate demonstrated its strong ability to penetrate the blood-brain barrier or regulate the intracranial microenvironment. With a high incidence of lung cancer brain metastases and limited treatment options, the outstanding performance of HLX43 in this area not only gives it a unique competitive advantage in post-line treatment of lung cancer, but also provides great potential for expansion to other solid tumors that are prone to brain metastases (such as breast cancer and melanoma). In addition, docetaxel is the standard second-line treatment for lung squamous cell carcinoma, but there has been a long absence of effective second-line treatment options for treatment-failed patients. In this patient population, HLX43 achieved a 38.5% ORR and a DCR of 84.6%, potentially setting a new standard in this area of treatment. Finally, the excellent safety profile of being "highly effective and low-toxic" is the "invisible cornerstone" for its long-term clinical application and commercial success. Data show that it has low hematological toxicity and overall good safety. This means that HLX43 not only has significant efficacy, but also good patient tolerance and compliance, creating favorable conditions for future combination therapy with other treatments (such as chemotherapy, targeted therapy) and exploring more frontline treatment scenarios, thus maximizing its commercial potential. In conclusion, the HLX43 update announced this time has far exceeded the concept validation stage. It has systematically demonstrated its comprehensive value as a "best-in-class" drug from multiple dimensions such as market coverage, solving clinical challenges, expanding broad-spectrum indications, and potential for future combination therapy. This is not only a technical success, but also a comprehensive preview of its commercial potential. Brokers are optimistic and capital markets recognize its innovative value The solid pace of HENLIUS' innovation transformation has already attracted high attention from top investment institutions. Just before the forum, the top international investment bank Goldman Sachs released its first research report covering HENLIUS, clearly giving it a "buy" rating and setting a 12-month target price of HK$100.70. Compared to the stock price at the time of the report, this target price indicates strong potential upside for the company. Goldman Sachs clearly stated in the report that HENLIUS is completing the strategic transformation from a pioneer in biosimilar drugs to a global innovative drug company, with the next generation IO-ADC (such as HLX43) as the core drive of its global pipeline layout. The report views the global potential of HLX43 as a key driver of the company's valuation, and particularly emphasizes its dual potential as "first-in-class" and "best-in-class". HLX43 has received FDA orphan drug designation for the treatment of thymic epithelial tumors (TET) in the United States, and concept verification data for more solid tumors such as cervical cancer, esophageal cancer, is also about to be read out, unlocking the product's value continuously. Goldman Sachs' view represents a consensus in the market: with core assets such as HLX43, HENLIUS has successfully positioned itself in the forefront of ADC and dual antibody technology, and its mature antibody engineering and ADC conjugation platform are injecting strong momentum into the company's long-term growth and valuation reshaping. In summary: data triggers value revaluation, innovative pipeline opens the global journey The successful convening of the international lung cancer forum and the announcement of stunning data on HLX43 have milestone significance for HENLIUS. It clearly indicates to the market that: First, HENLIUS' "innovation-driven" strategy has entered a period of harvest. The strong data demonstrated by HLX43 is a concentrated reflection of the company's years of focus on antibody design and ADC core technology, continuous consolidation of capabilities building and transformation, proving the company's ability to produce globally competitive innovative drugs. Second, HLX43 is expected to become the company's "game-changer" product in the field of lung cancer treatment and even the broader solid tumor market. Its "broad-spectrum" feature and ability to address clinical resistance pain points give it enormous market potential. With the advancement of key clinical trials and expansion of indications, HLX43 is poised to become the core pillar of the company's performance growth. Finally, the positive feedback from the capital markets will provide the company's innovative research and development with more "ammunition" and a more favorable environment. Obtaining a "buy" rating from authoritative institutions such as Goldman Sachs will help boost the company's liquidity, attract long-term value investors, and form a virtuous cycle of "innovation breakthrough - market value growth - research and development investment." Looking ahead, the prospects of HENLIUS are promising. With the continued advancement of innovative pipelines such as HLX43 and deepening global layout, this pharmaceutical company that is transitioning from China to the world is gaining more and more attention and recognition in the global biopharmaceutical arena.